Biosimilars

Biosimilars and Biologics - What are they?

What is a biologic?

Biologics are a class of treatments derived from living cells that target specific parts of the immune system treating a growing list of diseases. Currently there are biologics in Canada that are approved for psoriasis, psoriatic arthritis, and metastic melanoma, and others in the approval pipeline.

What is a Biosimilar?

Biosimilars are similar (not identical) versions of an existing biologic medication. Given that biologics are vastly more complex molecules than regular medications, manufacturers of SEBs cannot guarantee that their reproduction is identical to the originator drug. Unlike generics, where the active ingredient is the same, biosimilars are merely similar.

Health Canada has stated the following:

Biosimilars are not “generic” biologics. Authorization of a biosimilar is not a declaration of pharmaceutical or therapeutic equivalence to the reference biologic drug.